EP3730119B1 - Einheit zur biopharmazeutischen verwendung aus einer tasche und einem rahmen - Google Patents

Einheit zur biopharmazeutischen verwendung aus einer tasche und einem rahmen Download PDF

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Publication number
EP3730119B1
EP3730119B1 EP20170804.7A EP20170804A EP3730119B1 EP 3730119 B1 EP3730119 B1 EP 3730119B1 EP 20170804 A EP20170804 A EP 20170804A EP 3730119 B1 EP3730119 B1 EP 3730119B1
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EP
European Patent Office
Prior art keywords
weld
frame
peripheral edge
assembly
bag
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Active
Application number
EP20170804.7A
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English (en)
French (fr)
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EP3730119A1 (de
Inventor
Nelly Montenay
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sartorius Stedim FMT SAS
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Sartorius Stedim FMT SAS
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Publication of EP3730119A1 publication Critical patent/EP3730119A1/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers

Definitions

  • the invention relates to an assembly for biopharmaceutical use comprising a pocket adapted to receive a biopharmaceutical product and a frame.
  • biopharmaceutical product is meant here a product resulting from biotechnology, such as culture media, cell cultures, buffer solutions, artificial nutrition liquids, or a pharmaceutical product or more generally a product intended for use in the medical field.
  • a product is in liquid, pasty, powdery form, in one or more phases, homogeneous or not, capable of flowing through a valve, thus being able to be qualified as a fluid.
  • the invention also applies to products other than biopharmaceuticals, according to the definition which has just been given, but which are subject to similar requirements as regards their storage or their treatment.
  • the bag can be adapted for a bioreactor or a fermenter.
  • a bag receiving a biopharmaceutical product can for example be a single-use bag.
  • a pocket can comprise two walls. The two walls are sealed together, for example by a weld.
  • this type of pocket is able to expand. Once expanded, the pocket has a limited volume. Therefore, this type of pocket is commonly called a “2D pocket” (for “two dimensions”).
  • a single-use bag is generally made up of a film. More specifically, the walls of the pocket comprise a multilayer film.
  • the multilayer film comprises for example a contact layer, a barrier layer and an outer layer.
  • the contact layer is intended to be in contact with the biopharmaceutical product (in other words, the contact layer is on the side of the volume inside the pocket).
  • the contact layer is therefore made of a material compatible with the biopharmaceutical product without causing degradation of the film or of the biopharmaceutical product.
  • the material of the contact layer is generally selected from polyolefins such as for example polyethylene.
  • the outer layer is intended to be in contact with the external environment.
  • the outer layer contributes to the mechanical resistance of the walls of the pocket. To this end, it must be flexible enough to withstand high mechanical stresses, but not be too extensible in order to prevent any deformation of the bag when it is filled with a biopharmaceutical product.
  • the barrier layer serves as a barrier to the passage of gases such as oxygen, carbon dioxide and is generally made of ethylene vinyl alcohol.
  • the walls of the pocket must be hermetically sealed in order to prevent, for example, any leakage of product outside the pocket or any contamination of the product contained in the pocket.
  • the walls are generally welded together.
  • the materials making up the multilayer film are sometimes difficult to match in terms of welding.
  • the weld can yield, which leads to the loss of the integrity of the pocket.
  • the weld may yield when excessive forces are applied to the weld, when filling the pouch with a biopharmaceutical product, or in the event of overfilling.
  • the weld may also yield during transport or handling of the bag, in particular when the latter is filled with a biopharmaceutical product applying pressure to the weld.
  • the invention improves the situation.
  • an assembly for biopharmaceutical use comprising a pocket adapted to receive a biopharmaceutical product and a frame, the pocket being a flexible plastic envelope provided with at least one inlet/outlet port of biopharmaceutical fluid and comprising a first side wall and a second side wall, the first side wall and the second side wall being partly joined by a weld, the weld defining a welded perimeter of the pocket and delimiting an internal space of the pocket, the frame enclosing the pocket on a continuous path along of the welded periphery at least in one zone of the weld, the frame comprising a first part able to come into contact with the first side wall and a second part able to come into contact with the second side wall, the first part and the second part being fixed together by a fixing means applying a reinforcing pressure on the weld, the reinforcing pressure being between 10 N/m 2 and 100 N/m 2 .
  • the frame thus makes it possible to overcome the problems of weld breakage of the pocket while retaining its geometric characteristics and the materials of which it is composed.
  • the frame also makes it possible to reinforce the welding of the pocket, in particular when the pocket is made up of materials that are difficult to match for welding together.
  • FIG. 1 illustrates an assembly 20 for biopharmaceutical use.
  • the set includes a 22 pocket and a 24 frame.
  • Pocket 22 is illustrated in more detail in picture 2 .
  • the pocket 22 is rectangular in shape and substantially flat, and extends along a plane P (visible for example at figure 4 and at the figure 5 ).
  • a pocket as shown is commonly referred to as a 2D pocket.
  • the pocket 22 is a flexible plastic envelope.
  • Pouch 22 includes an inlet/outlet port 27 and first and second side walls 28, 30.
  • the flexible plastic envelope of the pocket 22 is for example composed of a multilayer film.
  • the multilayer film can for example be composed of polyethylene.
  • Polyethylene is particularly advantageous in terms of compatibility with the biopharmaceutical product intended to be contained in the bag 22.
  • the pocket 22 is further provided with at least one entry/exit port 27.
  • the entry/exit port 27 comprises a single orifice 26.
  • the input/output port 27 may comprise several orifices (for example four) without however departing from the scope of the present invention.
  • the inlet/outlet port 27 allows the passage of the biopharmaceutical fluid to the pocket 22 or to leave it.
  • the first side wall 28 and the second side wall 30 form the 2D shape of the pocket 22.
  • the first side wall 28 and the second side wall 30 are joined together by a weld 32.
  • the inlet port /outlet 27 is secured to the first and to the second side wall 28, 30 by direct welding of a piece of polyethylene, such as for example a shuttle comprising at least the inlet/outlet port 27, with the first and second walls lateral 28, 30.
  • Said input/output port being for example a connector with a tip of the fir tree type, often called “Hose Barb” in English.
  • the inlet-outlet port 27 is a tube made of plastic material (polyethylene, thermoplastic elastomer polymer) or silicone secured directly by welding to the first and to the second side wall 28, 30 of the pocket. More specifically, due to the presence of the entry/exit port 27, the first side wall 28 and the second side wall 30 are not welded together in the region of the entry/exit port 27.
  • the weld 32 defines a welded perimeter 34 of the pocket 22. More specifically, the first side wall 28 and the second side wall 30 are welded together by the weld 32 along the welded perimeter 34. As visible on the picture 2 , the welded perimeter 34 extends over the entire perimeter of the pocket 22, that is to say over a continuous path all around the pocket 22.
  • the weld 32 further defines an internal space 36 of the pocket 22. The internal space 36 is able to receive the biopharmaceutical product.
  • the weld 32 comprises an internal peripheral edge 37 on the side of the internal space 36 of the pocket and an external peripheral edge 38 opposite the internal peripheral edge 37.
  • the internal peripheral edge 37 delimits the internal space 36 of the pocket 22.
  • the weld 32 is substantially flat between the outer peripheral edge 38 and the inner peripheral edge 37.
  • the weld 32 extends in a radial direction R with respect to the pocket 22.
  • the weld 32 therefore extends radially from the internal space 36 moving away from it. More precisely, the radial direction R is located in the plane P, and extends perpendicular to the tangent T of the internal peripheral edge 37, in the opposite direction to the internal space 36.
  • weld 32 includes a width L32.
  • the width L32 is measured between the inner peripheral edge 37 and the outer peripheral edge 38. More precisely, the width L32 is measured along the radial direction R.
  • the width L32 can be between 5 mm and 20 mm. For example, the L32 width is 10 mm.
  • Frame 24 is substantially flat and rectangular.
  • the frame 24 is able to receive the pocket 22.
  • the frame 24 constitutes a support for the pocket 22.
  • the frame 24 applies a reinforcing pressure on the weld 32 of the pocket 22.
  • the material of the frame 24 is chosen to so that the frame 24 does not deform when pressure is applied to the pocket 22, and in particular when the weld 32 of the pocket 22 is subjected to pressure. This pressure on the weld 32 can be due for example to the transport or to the handling of the bag 22, in particular when the latter is filled with a biopharmaceutical product. Therefore, the frame 24 is for example made of plastic material.
  • the frame 24 comprises a first part 40 and a second part 42.
  • the first part 40 is able to come into contact with the first side wall 28 of the pocket 22.
  • the second part 42 is able to come into contact with the second side wall 30 from pocket 22.
  • the first part 40 constitutes the upper face of the frame 24.
  • the first part 40 is rectangular and flat.
  • the first part 40 further comprises a rectangular recess 41 in its center. It is through this recess 41 that the pocket 22 will be able to expand. More precisely, the shape of the first part 40 corresponds substantially to the shape of the weld 32 of the pocket 22.
  • the first part 40 comprises an outer periphery 44 and an inner periphery 43.
  • the outer periphery 44 is rectangular.
  • the inner periphery 43 is rectangular and corresponds to the contour of the recess 41.
  • the outer periphery 44 and the inner periphery 43 are spaced apart by a width L40.
  • the width L40 is between 1.2 times and 3 times the width of the weld L32.
  • the width L40 represents 1.5 times the width L32.
  • the width L40 is 20 mm.
  • the second part 42 is illustrated in particular at picture 3 .
  • the second part 42 constitutes the underside of the frame 24.
  • the second part 42 is rectangular and flat. More specifically, the second part 42 is in the form of a flat plate.
  • the external shape of the second part 42 corresponds to the external shape of the first part 40. In other words, the external dimensions of the second part 42 and of the first part 40 are identical.
  • the first part 40 and the second part 42 are fixed together by a fixing means 45 so as to apply a reinforcing pressure on the zone of the weld 32 in contact with the first part 40 and the second part 42.
  • the pressure reinforcement applied by the fixing means 45 on the weld 32 is a prestress which must make it possible to prevent the weld 32 from yielding.
  • the prestress applied is between 10 N/m 2 and 100 N/m 2 . This prestress allows the weld 32 to resist when the pocket 22 is subjected, for example, to a pressure in its internal space 36 of up to 1.5 bars. This is for example the case when the pocket 22 is filled with a biopharmaceutical product.
  • this prestress during the filling makes it possible to protect the weld 32 from a possible rupture. Since the weld 32 is only really subjected to pressure during filling, it may be possible to remove the frame 24 which encloses the pocket 22, once the pocket 22 has been filled. The frame 24 can therefore act as a temporary reinforcement for the weld 32 when the pocket 22 is filled. Alternatively or in addition, the frame 24 can act as a support during use, transport and/or storage. of pocket 22.
  • the fastening means 45 may consist, for example, of screw-nut assemblies distributed over the periphery of the first part 40 and of the second part 42.
  • the screw-nut assemblies in this case pass through the first part 40 and the second part 42 to join them together.
  • the fixing means 45 is a set of rivets, distributed over the periphery of the first part 40 and of the second part 42.
  • the fixing means 45 can be fixing lugs, preferably made of plastic or metal, engaging with the first part 40 and the second part 42. These tabs can further comprising a tab for their placement around the first and second parts 40, 42.
  • the frame 24 encloses the pocket 24 over the entire continuous path along the welded periphery 34.
  • the frame 24 covers the entire width L32 of the weld 32. More specifically, the width L40 of the first part 40 is greater than the width L32 so that the weld 32 is enclosed between the first part 40 and the second part 42 of the frame 24.
  • the frame 24 thus encloses the weld 32 from the outer peripheral edge 38 towards the inner peripheral edge 37, over the entire width L32.
  • the weld 32 is not exposed (that is to say not visible) in the recess 41.
  • the edge of the internal peripheral 43 of the first part 40 comes under the internal peripheral edge 37 of the weld 32.
  • the edge of the internal periphery 43 of the first part 40 comes beyond the internal peripheral edge 37 of the weld 32.
  • the weld 32 and a part of the pocket 22 directly in contact with the weld 32 is covered by the first part 40.
  • the frame 24 crushes not only the weld 32 but also a part of the pocket 22.
  • the width L40 can for example represent 1.5 times the width L32.
  • the edge of the internal peripheral 43 of the first part 40 can for example project beyond the weld 32, towards the internal space of the pocket 36, by 5 mm.
  • the frame 24 encloses the pocket 24 over the entire continuous path along the welded perimeter 34, but the frame 24 does not cover the entire width L32 of the weld 32.
  • the frame 24 covers part of the width L32 of welding.
  • the frame 24 thus encloses the weld 32 from the outer peripheral edge 38 towards the inner peripheral edge 37, over part of the width L32.
  • the weld 32 is partly exposed (i.e. visible) in the recess 41.
  • the length L40 is chosen so that the first part 40 covers the weld 32 sufficiently so that the frame 24 sufficiently reinforces the weld 32 in the event of pressure being applied to the weld 32.
  • FIG 7 illustrates another embodiment of a frame 24 according to the invention.
  • the first part 40 of the frame 24 comprises several recesses 41, so that the frame 24 can receive as many pockets 22 as the first part 40 comprises recess 41.
  • the frame 24 receives six pockets 22. Each pocket 22 is arranged at the level of a recess 41.
  • FIG 8 illustrates another embodiment of a frame 24 according to the invention.
  • the first part 40 and the second part 42 of the frame each comprise a recess 41. This alternative allows the inflation of the two side walls of the pocket 28, 30.
  • the first part 40 and the second part 42 each comprise several recesses 41.
  • Each recess 41 of the first part 40 is arranged opposite a recess 41 of the second part 42.
  • This alternative makes it possible both to receive as many pockets 22 as the first part 40 or the second part 42 comprises of recess 41 and to allow the swelling of the two side walls 28, 30 of the pockets 22 held in the frame 24.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Packages (AREA)
  • Bag Frames (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Claims (10)

  1. Einheit (20) zur biopharmazeutischen Verwendung, umfassend eine Tasche (22), die zum Aufnehmen eines biopharmazeutischen Produkts eingerichtet ist, und einen Rahmen (24), wobei die Tasche (22) eine flexible Kunststoffhülle ist, die mit mindestens einer Einlass-/Auslassöffnung (27) für biopharmazeutische Flüssigkeit ausgestattet ist und eine erste Seitenwand (28) und eine zweite Seitenwand (30) umfasst, wobei die erste Seitenwand (28) und die zweite Seitenwand (30) durch eine Schweißung (32) zum Teil fest verbunden ist, wobei die Schweißung (32) eine verschweißte Umrandung (34) der Tasche (22) definiert und einen Innenraum (36) der Tasche (22) abgrenzt,
    wobei der Rahmen (24)
    - die Tasche (22) auf einer kontinuierlichen Strecke entlang der verschweißten Umrandung (34) mit mindestens einer Zone der Schweißung (32) umgibt, und
    - einen ersten Teil (40), der dazu fähig ist, mit der ersten Seitenwand (28) in Kontakt zu kommen, und einen zweiten Teil (42), der dazu fähig ist, mit der zweiten Seitenwand (30) in Kontakt zu kommen, umfasst, wobei der erste Teil (40) und der zweite Teil (42) durch ein Befestigungsmittel (45) aneinander befestigt sind, das einen Verstärkungsdruck auf die Schweißung (32) anwendet, wobei der Verstärkungsdruck zwischen 10 N/m2 und 100 N/m2 liegt.
  2. Einheit (20) nach Anspruch 1, wobei die Tasche (22) durch die Schweißung (32) geschlossen ist, mit Ausnahme von der Zone, die die mindestens eine Einlass-/Auslassöffnung (27) umfasst, und der Rahmen (24) die Tasche (22) auf der Gesamtheit der kontinuierlichen Strecke entlang der geschweißten Umrandung (34) umgibt.
  3. Einheit (20) nach Anspruch 1 oder 2, wobei der erste Teil (40) des Rahmens (24) eine Aussparung (41) umfasst und der zweite Teil (42) des Rahmens (24) eine ebene Platte umfasst, so dass der Rahmen (24) die Tasche (22) umrahmt.
  4. Einheit (20) nach einem der Ansprüche 1 bis 3, umfassend mehrere Taschen (22), wobei der erste Teil (40) des Rahmens (24) mehrere Aussparungen (41) umfasst, wobei jede Aussparung (41) dazu fähig ist, eine der Taschen (22) aufzunehmen.
  5. Einheit (20) nach einem der vorhergehenden Ansprüche, wobei die Schweißung (32) einen inneren Umfangsrand (37) auf der Seite des Innenraums (36) der Tasche (22) und einen äußeren Umfangsrand (38), entgegengesetzt zu dem inneren Umfangsrand (37) umfasst, wobei die Schweißung (32) zwischen dem inneren Umfangsrand (37) und dem äußeren Umfangsrand (38) im Wesentlichen flach ist.
  6. Einheit (20) nach Anspruch 5, wobei die Schweißung (32) eine Breite (L32) umfasst, die zwischen dem inneren Umfangsrand (37) und dem äußeren Umfangsrand (38) gemessen wird, wobei die Breite (L32) zwischen 5 mm und 20 mm liegt.
  7. Einheit (20) nach Anspruch 6, wobei der Rahmen (24) die Schweißung (32) von dem äußeren Umfangsrand (38) zu dem inneren Umfangsrand (37) auf einem Teil der Breite (L32) umgibt.
  8. Einheit (20) nach Anspruch 6 oder 7 und einem der Ansprüche 1 bis 3, wobei der erste Teil (40) einen äußeren Umfang (44) und einen inneren Umfang (43) umfasst, wobei der äußere Umfang (44) und der innere Umfang (43) durch eine Breite (L40) voneinander beabstandet sind, wobei die Breite (L40) das 1,5-fache der Breite (L32) ausmacht.
  9. Einheit (20) nach Anspruch 6, wobei der Rahmen (24) die Schweißung (32) von dem äußeren Umfangsrand (38) zu dem inneren Umfangsrand (37) auf der gesamten Breite (L32) umgibt.
  10. Einheit (20) nach Anspruch 9, wobei der Rahmen (24) ferner einen Teil der Tasche (22) über die Schweißung (32) hinaus umgibt.
EP20170804.7A 2019-04-26 2020-04-22 Einheit zur biopharmazeutischen verwendung aus einer tasche und einem rahmen Active EP3730119B1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1904470A FR3095337B1 (fr) 2019-04-26 2019-04-26 Ensemble a usage biopharmaceutique comprenant une poche et un cadre

Publications (2)

Publication Number Publication Date
EP3730119A1 EP3730119A1 (de) 2020-10-28
EP3730119B1 true EP3730119B1 (de) 2023-05-03

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FR (1) FR3095337B1 (de)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11709156B2 (en) 2017-09-18 2023-07-25 Waters Technologies Corporation Use of vapor deposition coated flow paths for improved analytical analysis
US11709155B2 (en) 2017-09-18 2023-07-25 Waters Technologies Corporation Use of vapor deposition coated flow paths for improved chromatography of metal interacting analytes
US11918936B2 (en) 2020-01-17 2024-03-05 Waters Technologies Corporation Performance and dynamic range for oligonucleotide bioanalysis through reduction of non specific binding

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2113171B1 (de) * 2006-03-06 2016-11-02 Sartorius Stedim North America Inc. Systeme und Verfahren zum Einfrieren, Lagern und Auftauen biopharmazeutischer Materialien
US20130341354A1 (en) * 2012-06-26 2013-12-26 Gojo Industries, Inc. Portable liquid dispenser
US20180125756A1 (en) * 2016-11-04 2018-05-10 Corning Incorporated Glass bio-containers and methods for manufacturing the same

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FR3095337B1 (fr) 2021-05-28
FR3095337A1 (fr) 2020-10-30
EP3730119A1 (de) 2020-10-28

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